NCT06149585 Changes in Microbial Status From Dentate, Edentulous and After Dental Implant Placement
| NCT ID | NCT06149585 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Case Western Reserve University |
| Condition | Edentulous Mouth |
| Study Type | OBSERVATIONAL |
| Enrollment | 12 participants |
| Start Date | 2023-08-16 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 12 participants in total. It began in 2023-08-16 with a primary completion date of 2026-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The objectives of this study are to analyze the oral microbiome modulations occurring during the transition from partial (with some residual teeth) to full edentulous (without remaining teeth) status and implant placement in subjects affected by severe periodontitis; to evaluate if microbiome changes in relation to the used of different implant material/surface; and to assess the variance of the changes to determine the sample size for future longitudinal prospective studies.
Eligibility Criteria
Inclusion Criteria: 1. At least 21 years of age 2. Diagnosis of Stage III or IV periodontitis based on full mouth probing and full mouth x-rays 3. Planned for full mouth extraction and replacement by dental implants. 4. Rehabilitation with Implant supported restorations either maxilla and/ or mandible. 5. At least 2 implants available for examination. 6. No bone augmentation required. Exclusion Criteria: 1. Conditions requiring chronic routine prophylactic use of antibiotics. 2. Conditions requiring prolonged use of steroids. 3. History of leukocyte dysfunction and deficiencies 4. Bleeding disorders 5. History of neoplastic disease requiring use of radiation or chemotherapy 6. Metabolic bone disorders 7. Uncontrolled endocrine disorder 8. Use of any investigational drug or device within the 30 day period prior to implant surgery. 10\. Alcoholism or drug abuse 11. Patient infected with HIV 12. Condition or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, unreliability. Local Exclusion Criteria 1. Local inflammation 2. Mucosal disease such as erosive lichen planus 3. History of local irradiation therapy 4. Osseous lesion. 5. Active infection with suppuration or fistula track. 6. Persistent intraoral infection different than periodontitis
Contact & Investigator
Gian Pietro Schincaglia, DDS,PhD
PRINCIPAL INVESTIGATOR
Case Western Reserve University
Frequently Asked Questions
Who can join the NCT06149585 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Edentulous Mouth. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06149585 currently recruiting?
Yes, NCT06149585 is actively recruiting participants. Contact the research team at gxs486@case.edu for enrollment information.
Where is the NCT06149585 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT06149585 clinical trial?
NCT06149585 is sponsored by Case Western Reserve University. The principal investigator is Gian Pietro Schincaglia, DDS,PhD at Case Western Reserve University. The trial plans to enroll 12 participants.